A Clinical Trial Analyzing Effects of Prokinetic Drug on the Blood Glucose in Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Mosapride
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Mosapride, blood glucose, serum lipid
Eligibility Criteria
Inclusion Criteria:
- Male or female, age between 30-65 years old
- Type 2 diabetes
- Duration of diabetes less than 5 years and pancreatic function be in compensated stage.
- 7%≤HbA1C≤9%
- Patients are able to control diet and exercise by themselves in intervention period.
Exclusion Criteria:
- Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications.
- Type 2 diabetes using insulin, GLP-1 analogues or DPP-IV inhibitors).
- Heart function in NYHA Grade II-IV or history of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
- Hypohepatia (AST or ALT is two times higher than the upper limit) or history of cirrhosis, hepatic encephalopathy, esophageal varices or portal shunt.
- Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
- Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hyoxemia.
- Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
- Fertile woman without contraceptives.
- Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
- Allergic to or have contraindication to the intervention drugs.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Mosapride
Placebo
Arm Description
Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
Outcomes
Primary Outcome Measures
Change of fasting plasma glucose (FPG,mmol/L)
Change of OGTT 2 hour blood glucose(mmol/L)
Change of HbA1c(%)
Change of control rate of blood glucose(%)
Secondary Outcome Measures
Change of insulin release(uU/mL)
Change of C peptide release(nmol/L)
Change of HOMA-β[HOMA-β=20×(FINS,mIU/L)/((FPG,mmol/L)-3.5)]
Change of HOMA-IR [HOMA-IR=(FPG,mmol/L)×(FINS,mIU/L)/22.5]
Change of blood glucose variability(%)
Change of triglyceride(mmol/L)
Change of total cholesterol(mmol/L)
Change of LDL-c(mmol/L)
Change of HDL-c(mmol/L)
Change of Glucagon(pg/ml).
Change of GLP(pg/ml).
Change of GIP(pg/ml).
Change of DPP-IV(pg/ml).
Change of waist circumference (WC,cm)
Change of body mass index (BMI=weight(kg)/[height(m)2], kg/m2)
Change of body fat(%).
Change of carotid intima-media thickness (IMT,mm).
Change of 24-hours urine sodium(mmol/24h)
Change of 24-hours microalbumin(mg/L).
Change of 24-hours mALB/Cr(mg/g.Cr).
Change of inflammatory markers(hs-CRP,mg/L).
Incidence rate of newly-diagnosed hypertension(%).
Heart rate variability(HRV,%).
Change of clinic blood pressure and 24h mean blood pressure(mmHg).
Full Information
NCT ID
NCT02606617
First Posted
October 25, 2015
Last Updated
November 15, 2015
Sponsor
Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02606617
Brief Title
A Clinical Trial Analyzing Effects of Prokinetic Drug on the Blood Glucose in Patients With Type 2 Diabetes
Official Title
What is the Effects of Prokinetic Drug on the Blood Glucose in Type 2 Diabetes Patients: Mosapride Comparing Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University
4. Oversight
5. Study Description
Brief Summary
With the improvement of living level, the incidence rates of diabetes, obesity, and hypertension in China increased quickly, which are 11.6%, 7.1% and 18.8% respectively, according to the newly investigated data. The clustering of diabetes, obesity, hypertension and dyslipidemia increases the risk of cardiovascular events for patients. GLP-1 (glucagon like peptide-1) is a kind of incretin discovered in recent years. It was reported that beside its hypoglycemic and losing weight effects, activator of GLP-1 receptor could decrease blood pressure and improve lipid metabolism. Sleeve gastrectomy can improve the level of blood glucose and serum lipid of type 2 diabetic rats by ameliorate insulin level and insulin resistance, which may be related with the change of gastrointestinal hormones such as ghrelin and GLP-1. So, intervention of gastrointestinal tract and gastrointestinal hormone secretion may be a new therapy for glycolipids disorder and vascular complications. But, it is lack of evidence-based medicine proof on the relationship between prokinetic drug and glycolipids metabolism. So, the investigators designed a prospective, randomized, double-blinded, placebo control study, and try to evaluate the effects of prokinetic drug (Mosapride) on the blood glucose and serum lipid in type 2 diabetic patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Mosapride, blood glucose, serum lipid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mosapride
Arm Type
Active Comparator
Arm Description
Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
Intervention Type
Drug
Intervention Name(s)
Mosapride
Intervention Description
Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
Primary Outcome Measure Information:
Title
Change of fasting plasma glucose (FPG,mmol/L)
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of OGTT 2 hour blood glucose(mmol/L)
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of HbA1c(%)
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of control rate of blood glucose(%)
Time Frame
Baseline, 24weeks (End of Trial)
Secondary Outcome Measure Information:
Title
Change of insulin release(uU/mL)
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of C peptide release(nmol/L)
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of HOMA-β[HOMA-β=20×(FINS,mIU/L)/((FPG,mmol/L)-3.5)]
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of HOMA-IR [HOMA-IR=(FPG,mmol/L)×(FINS,mIU/L)/22.5]
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of blood glucose variability(%)
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of triglyceride(mmol/L)
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of total cholesterol(mmol/L)
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of LDL-c(mmol/L)
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of HDL-c(mmol/L)
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of Glucagon(pg/ml).
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of GLP(pg/ml).
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of GIP(pg/ml).
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of DPP-IV(pg/ml).
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of waist circumference (WC,cm)
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of body mass index (BMI=weight(kg)/[height(m)2], kg/m2)
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of body fat(%).
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of carotid intima-media thickness (IMT,mm).
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of 24-hours urine sodium(mmol/24h)
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of 24-hours microalbumin(mg/L).
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of 24-hours mALB/Cr(mg/g.Cr).
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of inflammatory markers(hs-CRP,mg/L).
Time Frame
Baseline, 24weeks (End of Trial)
Title
Incidence rate of newly-diagnosed hypertension(%).
Time Frame
Baseline, 24weeks (End of Trial)
Title
Heart rate variability(HRV,%).
Time Frame
Baseline, 24weeks (End of Trial)
Title
Change of clinic blood pressure and 24h mean blood pressure(mmHg).
Time Frame
Baseline, 24weeks (End of Trial)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, age between 30-65 years old
Type 2 diabetes
Duration of diabetes less than 5 years and pancreatic function be in compensated stage.
7%≤HbA1C≤9%
Patients are able to control diet and exercise by themselves in intervention period.
Exclusion Criteria:
Type 2 diabetes with serious complications, such as diabetic neuropathy, diabetic retinopathy, stage IV diabetic nephropathy, or acute diabetic complications.
Type 2 diabetes using insulin, GLP-1 analogues or DPP-IV inhibitors).
Heart function in NYHA Grade II-IV or history of cardio-cerebral vascular events such as congestive heart failure, myocardial infarction or stroke within 3 months.
Hypohepatia (AST or ALT is two times higher than the upper limit) or history of cirrhosis, hepatic encephalopathy, esophageal varices or portal shunt.
Renal insufficiency ( serum creatinine is 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
Chronic obstructive pulmonary disease (COPD), chronic respiratory failure or hyoxemia.
Acute infections, tumor, severe arrhythmia, mental disorders, alcohol or medicine addiction.
Fertile woman without contraceptives.
Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
Allergic to or have contraindication to the intervention drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhu Zhiming, MD, PhD
Phone
86-023-68767849
Email
zhuzm@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhong Jian, MD
Phone
86-023-68757883
Email
zhongjian2000@21cn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhu Zhiming, MD, PhD
Organizational Affiliation
The third hospital affiliated to the Third Military Medical University. China
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial Analyzing Effects of Prokinetic Drug on the Blood Glucose in Patients With Type 2 Diabetes
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